在偏差调查过程中,CAPA 制定的有效性尤为重要,首先需要符合SMART原则,另外,一个有效的CAPA可以通过以下几个考量点进行检查,可以作为一个checklist 作为辅助工具:
- Does the corrective/preventive actions address the root cause/contributing factor?
- Are the corrective/preventive actions foucus on prevention or proof? If not why not?
- Are the corrective/preventive actions sustainable?
- Challenge the corrective actions to ensure that they will prevent re-occurrence?
- Can a unfamiliar reader understand and implement the corrective/preventive action?
- Is this action going to have a negative impact on subsequent processes and related systems?
- If the corrective/preventive action will take time to implement, is there an interim action to prevent re-occurrence?
- Have Process owners / end users been consulted?
- What is the plan to inform process owners / end users of new actions?
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